RecruitingNot ApplicableNCT06405217

Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment

Safety and Efficacy of Recombinant Human Thyroid Stimulating Hormone for Radioiodine 131I Treatment in Patients With Locally Advanced/Metastatic Differentiated Thyroid Cancer


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

30 participants

Start Date

Apr 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Subjects: patients with postoperative local recurrent or metastatic differentiated thyroid cancer . Experimental group: Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days. Control group: Thyroid hormone withdraw for 4-6 weeks. The two groups were treated with radioiodine 131I after plasma thyroid stimulating hormone elevated (\>30mU/L). The efficacy and adverse reactions were observed.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a hormone medication called recombinant human TSH (rhTSH) — which stimulates thyroid tissue to absorb radioactive iodine — can improve the effectiveness of radioactive iodine (I-131) treatment for patients with thyroid cancer that has returned or spread after surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have differentiated thyroid cancer (the most common type) that came back or spread after a complete or near-complete thyroid removal - Your cancer has been confirmed by imaging, blood markers, or biopsy - You have at least one measurable lesion - Your general health score (ECOG) is 0–2 and you are expected to live more than 3 months - Your blood counts and organ function are within required ranges - Women of childbearing age must use effective contraception and have a negative pregnancy test before starting **You may NOT be eligible if...** - You have uncontrolled high blood pressure, severe heart disease, or uncontrolled diabetes - You are pregnant or breastfeeding - You have active serious infections or other conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant Human Thyroid Stimulating Hormone

Recombinant human thyroid stimulating hormone injection: 0.9mg/1.0mL/piece; intramuscular injection; once a day for two consecutive days


Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT06405217


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